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EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2014. Statement on theupdate of the list of QPS-recommended biological agents intentionally added to foodor feed as notified to EFSA 1: Suitability of taxonomic units notified to EFSA untilOctober 2014

EFSA Publication

Link to article, DOI:10.2903/j.efsa.2014.3938

Publication date:2014

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Citation (APA):EFSA Publication (2014). EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2014. Statement on theupdate of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA1: Suitability of taxonomic units notified to EFSA until October 2014. Europen Food Safety Authority. the EFSAJournal, No. 3938, Vol.. 12(12) https://doi.org/10.2903/j.efsa.2014.3938

https://doi.org/10.2903/j.efsa.2014.3938

https://orbit.dtu.dk/en/publications/753d1749-fb5d-4d45-8c4a-ea03402148cd

https://doi.org/10.2903/j.efsa.2014.3938

EFSA Journal 2014;12(12):3938

Suggested citation: EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2014. Statement on the update of the list of

QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 1: Suitability of taxonomic units

notified to EFSA until October 2014. EFSA Journal 2014;12(12):3938, 41 pp. doi:10.2903/j.efsa.2014

Available online: www.efsa.europa.eu/efsajournal

© European Food Safety Authority, 2014

SCIENTIFIC OPINION

Statement on the update of the list of QPS-recommended biological agents

intentionally added to food or feed as notified to EFSA 1: Suitability of

taxonomic units notified to EFSA until October 20141

EFSA Panel on Biological Hazards (BIOHAZ)2, 3

European Food Safety Authority (EFSA), Parma, Italy

ABSTRACT

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for

market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified

presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to

support safety risk assessments performed by EFSA’s scientific Panels. The safety of unambiguously defined

biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended),

and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are,

where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for

a QPS status. A total of 99 biological agents were notified to EFSA between May 2013 and October 2014. From

those, 26 biological agents already had a QPS status and were not further evaluated, and 54 were also not

included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS

activities since 2014. The remaining 19 notifications were considered for the assessment of the suitability for the

QPS list. These 19 notifications referred to 13 taxonomic units which were evaluated for the QPS status, three of

which were recommended for the QPS list: a) Carnobacterium divergens, with the qualification of absence of

acquired antibiotic resistance determinants; b) Microbacterium imperiale, only for enzyme production, and

c) Candida cylindracea, only for enzyme production.

© European Food Safety Authority, 2014

KEY WORDS

safety, QPS, bacteria, yeast, Carnobacterium divergens, Microbacterium imperiale, Candida cylindracea

1 On request from EFSA, Question No EFSA-Q-2014-00611, adopted on 4 December 2014. 2 Panel members: Olivier Andreoletti, Dorte Lau Baggesen, Declan Bolton, Patrick Butaye, Paul Cook, Robert Davies,

Pablo S. Fernandez Escamez, John Griffin, Tine Hald, Arie Havelaar, Kostas Koutsoumanis, Roland Lindqvist, James

McLauchlin, Truls Nesbakken, Miguel Prieto Maradona, Antonia Ricci, Giuseppe Ru, Moez Sanaa, Marion Simmons,

John Sofos and John Threlfall. Correspondence: [email protected] 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on QPS: Miguel Prieto Maradona,

Amparo Querol, Christophe Nguyen-the, Güenter Klein, Ingvar Sundh, Juan E. Suarez, Luisa Peixe, Pablo S. Fernandez

Escamez, Pier Sandro Cocconcelli and Just Vlak for the preparatory work on this scientific opinion, and EFSA staff:

Sandra Correia and Winy Messens for the support provided to this scientific opinion.

mailto:[email protected]

BIOHAZ statement on QPS: suitability of taxonomic units notified to October 2014

EFSA Journal 2014;12(12):3938 2

SUMMARY

The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) to

deliver a Scientific Opinion on the maintenance of the list of QPS biological agents intentionally

added to food or feed (2013 update). The question included three specific tasks in the terms of

reference (ToR).

The BIOHAZ Panel decided to change the evaluation procedure: the publication of the overall

assessment of the taxonomic units previously recommended for the QPS list (EFSA, 2013) will be

carried out after three years in a scientific opinion of the BIOHAZ Panel (December 2016) but in any

case, that list of microorganisms will be maintained and frequently checked based on the evaluation of

extensive literature reviews which will be updated regularly with new publications. Intermediate

deliverables in the form of a Panel statement will be produced and published, should an assessment for

a QPS classification of a microbiological agent notified to EFSA be requested by the Feed Unit, the

Food Ingredients and Packaging (FIP) Unit, the Nutrition Unit and by the Pesticides Unit. Evaluations

of these notifications will be compiled in a single statement for periods of around six months. The

results of these assessments will also be included in the scientific opinion of the BIOHAZ Panel to be

published until December of 2016. The “2013 updated list of QPS status recommended biological

agents for safety risk assessments carried out by EFSA scientific Panels and Units”, will be appended

to each Panel statement. New biological agents recommended for the QPS status will be included in

that list, after the assessment of the new notifications evaluated for each Panel statement.

The first ToR required to keep updated the list of biological agents being notified, in the context of a

technical dossier to EFSA Units (such as Feed, Food Ingredients and Packaging (FIP), Nutrition and

Pesticides), for intentional use in feed and/or food or as sources of food and feed additives, enzymes

and plant protection products for safety assessment. The list was updated with the notifications

received since the last review and it is appended to the current statement. Notifications considered for

the current statement were received between May 2013 and October 2014. Within this period,

99 notifications were received from those four Units, of which, 47 from Feed, 44 from FIP, 3 from

Nutrition and 5 from Pesticides.

The second ToR concerns the revision of the taxonomic units previously recommended for the QPS

list and their qualifications (especially the qualification regarding antimicrobial resistance) when new

information has become available and to update the information provided in the previous opinion

(EFSA, 2013) where appropriate. The work being developed in order to reply to this ToR is not

reflected in the current statement, but will be published in a scientific Opinion of the BIOHAZ Panel

until December of 2016 as previously mentioned.

The third ToR required a (re)assessment of the suitability of taxonomic units notified to EFSA not

present in the current QPS list for their inclusion in the updated list. The current statement focusses on

this ToR by including the individual assessments of the taxonomic units not previously included in the

2013 QPS list. Of those 99 notifications received, 26 biological agents already had a QPS status and

were not further evaluated in this statement. From the remaining 73 (without a QPS status), 54 were

not further assessed as they are filamentous fungi or enterococci, biological groups which have been

excluded from QPS activities since 2014 and 19 were considered for the assessment of the suitability

of the respective taxonomic units for inclusion for the QPS list. Sixteen species were notified to the

Feed Unit, 2 to the FIP Unit and one to the Nutrition Unit. The respective taxonomic units (13 in total)

were assessed for their suitability for the QPS list. Of a total of 12 bacterial taxonomical units

evaluated, 10 were notified to the Feed Unit (Actinomadura roseorufa, Bacillus toyonensis (previously

B. cereus var. toyoi), Carnobacterium divergens, Clostridium butyricum, Escherichia coli,

Paenibacillus lentus, Streptomyces albus, Streptomyces aureofaciens, Streptomyces lasaliensis,

Streptomyces cinnamonensis), one to the FIP Unit (Microbacterium imperiale) and one to the

Nutrition Unit (Bacteroides xylanisolvens). The only yeast taxonomic unit evaluated was notified to

the FIP Unit (Candida cylindracea). After the assessment, which is included in the current statement,

three taxonomic units were recommended for the QPS list: a) Carnobacterium divergens, with the


EFSA Journal 2014;12(12):3938 3

qualification of absence of acquired antibiotic resistance determinants; b) Microbacterium imperiale,

only for enzyme production, and c) Candida cylindracea, only for enzyme production.


EFSA Journal 2014;12(12):3938 4

TABLE OF CONTENTS

Abstract .................................................................................................................................................... 1 Summary .................................................................................................................................................. 2 Background as provided by EFSA ........................................................................................................... 5 Terms of reference as provided by EFSA ................................................................................................ 5 Evaluation ................................................................................................................................................. 7 1. Introduction ..................................................................................................................................... 7 2. Methodology .................................................................................................................................... 7 3. Bacteria ............................................................................................................................................ 9

3.1. Actinomadura roseorufa ......................................................................................................... 9 3.2. Bacillus toyonensis (previously B. cereus var. toyoi) ............................................................. 9 3.3. Bacteroides xylanisolvens ..................................................................................................... 10 3.4. Carnobacterium divergens .................................................................................................... 11 3.5. Clostridium butyricum .......................................................................................................... 12 3.6. Escherichia coli .................................................................................................................... 12 3.7. Microbacterium imperiale .................................................................................................... 13 3.8. Paenibacillus lentus .............................................................................................................. 14 3.9. Streptomyces albus ................................................................................................................ 14 3.10. Streptomyces aureofaciens .................................................................................................... 15 3.11. Streptomyces cinnamonensis ................................................................................................ 16 3.12. Streptomyces lasaliensis ....................................................................................................... 17 3.13. General conclusion for the genus Streptomyces on a recommendation for the QPS list ...... 18

4. Yeast .............................................................................................................................................. 18 4.1. Candida cylindracea ............................................................................................................. 18

Conclusions and recommendations ........................................................................................................ 19 References .............................................................................................................................................. 20 Appendices ............................................................................................................................................. 28 Appendix A. The 2013 updated list of QPS Status recommended biological agents in support of

EFSA risk assessments – 1st revision (new additions) ........................................................................... 28

Appendix B. Microbial species as notified to EFSA received (May 2013 and October 2014) ....... 30 Abbreviations ......................................................................................................................................... 41


EFSA Journal 2014;12(12):3938 5

BACKGROUND AS PROVIDED BY EFSA

A wide variety of microorganisms (including viruses) are intentionally added at different stages into

the food chain, either directly or as a source of additives or food enzymes or plant protection products.

EFSA is requested to assess the safety of these biological agents in the context of applications for

market authorisation as sources of food and feed additives, enzymes and plant protection products

received by EFSA.

The Scientific Committee reviewed the range and numbers of microorganisms likely to be the subject

of an EFSA Opinion and in 2007 published a list of microorganisms recommended for Qualified

Presumption of Safety (QPS list),4,5

consisting of 48 species of Gram-positive non-sporulating

bacteria, 13 Bacillus species and 11 yeast species. Filamentous fungi were also assessed but these

were not recommended for QPS status. The Scientific Committee recommended that a QPS approach

should be implemented across EFSA and applied equally to all safety considerations of

microorganisms that EFSA is required to assess. The Scientific Committee recognised that there

would have to be continuous provision for reviewing and modifying the QPS list. The EFSA Panel on

Biological Hazards (BIOHAZ) took the prime responsibility for this and annually reviewed the

existing QPS list, as recommended by the Scientific Committee.

In the first annual QPS review and update,6 the existing QPS list was reviewed and EFSA’s initial

experience in applying the QPS approach was described. The potential application of the QPS

approach to microbial plant protection products was discussed in the 2009 review.7 In 2009, viruses

and bacteriophages were assessed for the first time, leading to the addition of two virus families used

for plant protection purposes to the QPS list. Bacteriophages were not considered appropriate for the

QPS list. After consecutive years of updating the existing scientific knowledge, the filamentous fungi

(2008 to 2013 update) and enterococci (2010-2013 update) were not recommended for the QPS list.

The 2013 update of the recommended QPS list includes 53 species of Gram-positive non-sporulating

bacteria, 13 Gram-positive spore forming bacteria (Bacillus species), 1 Gram-negative bacterium

(Gluconobacter oxydans), 13 yeast species, and 3 virus families. No QPS recommended species has

been taken down from the list following six (2008-2013 update) annual reviews.

Based on the above mentioned information, the BIOHAZ Panel at their plenary meeting in January

2014, made a proposal for future QPS activities that was discussed at the Scientific Committee

meeting in February 2014. The Scientific Committee agreed to exclude some biological groups

(filamentous fungi, bacteriophages and enterococci) in future QPS activities, while an extensive

literature review of the QPS recommended list could be done less frequently. The deadline for the

assessment of the suitability of new taxonomic units notified to EFSA for inclusion in the QPS list

would be tailored to the needs of the requesting EFSA Units and/or Scientific Panels.

TERMS OF REFERENCE AS PROVIDED BY EFSA

ToR 1: Keep updated the list of biological agents being notified, in the context of a technical dossier to

EFSA Units (such as Feed, Pesticides, Food Ingredients and Packaging, and Nutrition), for intentional

use in feed and/or food or as sources of food and feed additives, enzymes and plant protection

products for safety assessment.

4 Opinion of the Scientific Committee on a request from EFSA related to a generic approach to the safety assessment by

EFSA of microorganisms used in food/feed and the production of food/feed additives. The EFSA Journal 2005, 226, 1-12. 5 Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to

EFSA - Opinion of the Scientific Committee. The EFSA Journal 2007, 293, 1-85. 6 Scientific Opinion of the Panel on Biological Hazards on a request from EFSA on the maintenance of the list of QPS

microorganisms intentionally added to food or feed. The EFSA Journal 2008, 923, 1-48. 7 Scientific Opinion of the Panel on Biological Hazards (BIOHAZ) on the maintenance of the list of QPS microorganisms

intentionally added to food or feed (2009 update). EFSA Journal 2009; 7(12):1431, 92 pp. doi:10.2903/j.efsa.2009.1431.


EFSA Journal 2014;12(12):3938 6

ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications

(especially the qualification regarding antimicrobial resistance) when new information has become

available. Update the information provided in the previous opinion where appropriate.

ToR 3: (Re) assess the suitability of taxonomic units notified to EFSA not present in the current QPS

list for their inclusion in that list.


EFSA Journal 2014;12(12):3938 7

EVALUATION

1. Introduction

A wide variety of microorganisms (including viruses) are intentionally added at different stages into

the food chain, either directly or as a source of food and feed additives, enzymes or plant protection

products. In the context of applications for market authorisation of these biological agents, EFSA is

requested to assess their safety.

Qualified Presumption of Safety (QPS) entered EU law with the publication of a new Commission

Implementing Regulation (EU) No 562/20128 amending Commission Regulation (EU) No 234/2011

9

with regard to specific data required for risk assessment of food enzymes. If the microorganism used

in the production of a food enzyme has a status of QPS according to the most recent list of QPS

recommended biological agents adopted by the European Food Safety Authority (EFSA), the enzyme

application should not be required to include toxicological data. If residues, impurities and degradation

products linked to the total enzyme production process (production, recovery and purification) could

give rise for concern, the Authority, pursuant to Article 6(1) of Regulation (EC) No 1331/2008,10

may

request additional data for risk assessment, including toxicological data.

The QPS approach was developed by the Scientific Committee to provide a generic concept to

prioritise and to harmonise risk assessment within EFSA of microorganisms intentionally introduced

into the food chain, in support of the respective Scientific Panels and Units in the frame of

authorisations (Butaye et al., 2003). The list, first established in 2007 has been revised and updated.

Taxonomic units were included in the QPS list either following notifications to EFSA or following

proposals made by stakeholders during a public consultation in 2005, even if they were not yet

notified to EFSA (EFSA BIOHAZ Panel, 2013). For the 2014 update, it was decided to change the

procedures. The publication of the overall assessment of the taxonomic units previously recommended

for the QPS list (EFSA BIOHAZ Panel, 2013) will be carried out less frequently (every three years)

through a scientific opinion of the BIOHAZ Panel. In any case, the recommendations provided

concerning that list of microorganisms will be maintained and frequently checked based on the

evaluation of extensive literature reviews which will be updated regularly with new publications.

Intermediate deliverables in the form of a Panel statement will be produced and published, should an

assessment for a QPS classification of a microbiological agent notified to EFSA be requested by Feed,

Food Ingredients and Packaging (FIP), Nutrition or Pesticides Units. Evaluations of these notifications

will be compiled in a single statement for periods of around six months. The results of these

assessments will also be included in the scientific opinion to be published in December of 2016. The

“2013 updated list of QPS status recommended biological agents for safety risk assessments carried

out by EFSA Scientific Panels and Units”, will be appended to each Panel statement. New biological

agents recommended for the QPS status will be included in that list, after the assessment of the new

notifications by the BIOHAZ Panel.

2. Methodology

In response to ToR1, the EFSA Units (Feed, FIP, Nutrition and Pesticides Units), have been asked to

update the list of biological agents being notified to EFSA. For the current statement, 99 notifications

were received between May 2013 and October 2014, of which, 47 from Feed, 44 from FIP, 3 from

Nutrition and 5 from Pesticides.

8 Commission Implementing Regulation (EU) No 562/2012 of 27 June 2012 amending Commission Regulation (EU) No

234/2011 with regard to specific data required for risk assessment of food enzymes. OJ L 168, 28.6.2012, p. 21-23. 9 Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the

European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes

and food flavourings. OJ L 64, 11.3.2011, p. 15-24. 10 Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a

common authorisation procedure for food additives, food enzymes and food flavourings. OJ L354, 31.12.2008, p. 1-6.


EFSA Journal 2014;12(12):3938 8

In response to ToR3, from those 99 notifications, 26 biological agents already had a QPS status and

were not further evaluated neither the 54 biological agents that are filamentous fungi or enterococci,

biological groups which have been excluded from QPS activities (in the follow up of a

recommendation of the QPS 2013 update (EFSA BIOHAZ Panel, 2013)). The remaining 19 biological

agents were assessed for the suitability of the respective taxonomic units for inclusion in the QPS list.

From the assessed taxonomic units, 16 species were notified to the Feed Unit, 2 to the FIP Unit and

one to the Nutrition Unit. The respective taxonomic units (total of 13) were assessed for their

suitability to the QPS list. Of a total of 12 bacterial taxonomical units evaluated, 10 were notified to

the Feed Unit (Actinomadura roseorufa, Bacillus toyonensis (previously B. cereus var. toyoi),

Carnobacterium divergens, Clostridium butyricum, Escherichia coli, Paenibacillus lentus,

Streptomyces albus, Streptomyces aureofaciens, Streptomyces lasaliensis, Streptomyces

cinnamonensis), one to the FIP Unit (Microbacterium imperiale) and one by the Nutrition Unit

(Bacteroides xylanisolvens). The only yeast taxonomic unit evaluated was notified to the FIP Unit

(Candida cylindracea).

The procedure followed for this assessment is the same as in the previous QPS 2013 update of the

scientific opinion.

Table 1: Notifications received by EFSA Units (Feed, FIP, Nutrition and Pesticides Units) and by

biological group from May 2013 until October 2014

Unit/ Panel Not QPS Already QPS Grand Total

Biological group Not evaluated Evaluated

Feed/FEEDAP 16 16 15 47

Bacteria 1 16 9 26

Filamentous fungi 15 15

Yeasts 6 6

FIP/CEF 34 2 8 44

Bacteria 1 6 7

Filamentous fungi 34 1 35

Yeasts 1 1 2

Nutrition/NDA 1 2 3

Bacteria 1 1 2

Yeasts 1 1

Pesticides/PPR 4 1 5

Filamentous fungi 4 4

Viruses 1 1

Grand Total 54 19 26 99

For the taxonomic units associated with the notifications compiled within the time period covered by

this statement (from May 2013 until October 2014), the literature review was broader in order to

consider the identity, the body of knowledge, history of use and the potential safety concerns.

Relevant databases such as PubMed, Web of Knowledge, CasesDatabase, GoogleScholar, CAB

Abstracts or Food Science Technology Abstracts (FSTA) were searched using specific sections.

Keywords used may equally be specified in the specific section. Some common keywords such as the

taxonomic unit in combination with ‘toxin’, ‘disease’, ‘infection’, ‘clinical’, ‘virulence’,

‘antimicrobial and/or antibiotic/antimycotic resistance’, ‘safety’, ‘risk’, ‘abortion’, ‘urinary’,

‘mastitis’, ‘syndrome’, ‘vaginitis’. In addition some animal categories such as ‘poultry’, ‘chicken’,

‘hen’, ‘broiler’, ‘turkey’, ‘fowl’, ‘piglet’, ‘pig’, ‘calf’, ‘calves’, ‘cattle’, ‘cow’, ‘fish’ and ‘salmon’

were generally applied. Relevant studies were evaluated, reported and discussed. The search terms

were broad and covered synonyms or former names of taxonomic units.


EFSA Journal 2014;12(12):3938 9

3. Bacteria

3.1. Actinomadura roseorufa

Identity

The genus Actinomadura consists of Gram-positive actinobacteria belonging to the order

Actinomycetales, (fam. Thermomonosporaceae) and is composed of microorganisms with cell walls

containing meso-2,6-diaminopimelic acid and madurose but lacking arabinose and galactose.

Actinomadurae are chemo-organotrophs that produce stable vegetative mycelia and aerial hyphae

differentiating into spore chains. The genus currently contains 37 species including 2 subspecies

(Euzéby and Tindall, online) and they are known to produce bioactive secondary metabolites. The

taxonomy identification of this bacterium is not established as a species with a validated name in

IJSEM and LPSN.11

Actinomadura roseorufa is notified as a producer of semduramicin, a polyether ionophor (Microbial

Genomes, online), to be used as a feed supplement acting as a coccidiostat to inhibit intestinal coccidia

(Rutkowski and Brzezinski, 2013). No strain belonging to this species has been fully sequenced

according to NCBI (Microbial Genomes, online).

Body of knowledge

No scientific reports or articles on the safety of A. roseorufa have been found. A search in the

Thomson Reuters Web of Science (1 October 2014) using “Actinomadura roseorufa” as search term in

“topic” retrieved 9 hits all related to the production and properties of semduramicin. The body of

knowledge is limited to the use of strains as producers of this compound. Since A. roseorufa produces

semduramicin, its use in feed might promote bacterial resistance.

The safety of semduramicin when used as coccidiostat for fattening of chickens has been assessed by

EFSA (EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2011).

The general conclusion from this report is that on the basis of the data provided on semduramicin

sodium for use as feed additive under the proposed conditions of use, the safety of semduramicin is

demonstrated for the target animal, the user, the consumer and the environment. Consequently, an

additive containing semduramicin has been authorized as cocciodiostat in the EU (EFSA Panel on

Additives and Products or Substances used in Animal Feed (FEEDAP), 2011).

Safety concerns

A. roseorufa produces semduramicin, an approved coccidiostat, with antimicrobial activity. The

possible contribution of this ionophore to the development of antibiotic resistance to important human

antibiotics is a matter of concern. No studies on the safety of A. roseorufa were found. Therefore no

definitive conclusions can be attained. There is a limited number of reports from EFSA on the safety

concerns of semduramicin (EFSA Panel on Additives and Products or Substances used in Animal Feed

(FEEDAP), 2011).

Conclusions on a recommendation for the QPS list

A. roseorufa produces semduramicin, an approved coccidiostat, with antimicrobial activity and

therefore cannot be considered for the QPS list. Moreover its identity is not well established.

3.2. Bacillus toyonensis (previously B. cereus var. toyoi)

Identity

The species Bacillus toyonensis was recently published in the validation list no 155 (Oren and Garrity,

2014).

11

http://www.bacterio.net/

http://www.bacterio.net/


EFSA Journal 2014;12(12):3938 10

The phylogenetic analysis of the 16S rRNA, 23S rRNA and of the gyrB gene sequences and average

nucleotide identity calculations, derived from the whole genome sequence indicate that the species

B. toyonensis belongs to the B. cereus group or B. cereus sensu lato (Jimenez et al., 2013).

Body of knowledge

B. toyonensis was originally called B. cereus var. toyoi, and was represented by a single strain

authorized in the past in the EU as a feed additive for various farm animal species (EFSA, 2004, 2005,

2007a, b; Williams et al., 2009). The body of knowledge concerns therefore, only one strain and not a

generic taxonomic unit. Similarly, a publication (Jimenez et al., 2013) describes B. toyonensis on the

basis of one strain.

Safety concerns

B. toyonensis was included before 2013 within the species B. cereus (EFSA, 2004, 2005, 2007a,

2007b; Williams et al., 2009). Therefore, the safety concerns defined for B. cereus, which led to the

conclusion in 2007 (EFSA, 2007c) that B. cereus and related species (such as B. thuringiensis) should

not be included in the QPS list, apply to B. toyonensis, unless specific information could relieve these

concerns. Jimenez et al. (2013) do not provide any specific information for B. toyonensis with regards

to the toxins known to be produced by the B. cereus group. The safety of the only described

B. toyonensis strain intended to be used as a feed additive has recently been reassessed by EFSA

(EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2012; EFSA

FEEDAP Panel, 2014). These assessments concluded that this strain has the capacity to produce

functional B. cereus toxins. All the above information concerns a single strain, and cannot be extended

to the B. toyonensis species, should more strains of the species were described.


In conclusion, Bacillus toyonensis cannot be proposed for the QPS list because it is a member of the

B. cereus group, and because of the absence of evidences at the species level that it does not present

safety concerns.

3.3. Bacteroides xylanisolvens

Identity

The first report on Bacteroides xylanisolvens (Chassard et al., 2008) described the new species mainly

based on 16S rRNA sequence and carbohydrate metabolism differences to other Bacteroides. The type

strain was also designated. Presently, there are five strains that received attention, all of which were

defined by their 16S rRNA sequences. One strain was isolated from human feces (Ulsemer et al.,

2012a), two based on their capacity to ferment xylan (Chassard et al., 2008; Mirande et al., 2010) and

the other two after growing on cellulose (Ramaraj et al., 2014). Draft genome sequences have been

deposited for these last two and the type strain.

Body of knowledge

The body of knowledge of the species in mainly based on its ability to ferment carbohydrates

(Chassard et al., 2008; Mirande et al., 2010; Ramaraj et al., 2014). No record of its use in food

fermentation processes exists, and only a couple of pilot studies using fermented milk were performed

(Ulsemer et al., 2012b). Therefore the body of knowledge on use of B. xylanisolvens as a food or feed

ingredient is limited.

Safety concerns

Tests on the safety of B. xylanisolvens have been mainly performed in vitro (Mirande et al., 2010;

Ulsemer et al., 2012a, c) although some studies on mice, mainly intraperitoneal injection of live

bacteria, indicate that the pathogenic potential of the strain used may be low (Ulsemer et al., 2012c).

Finally, two complementary pilot studies with healthy volunteers that received orally administered


EFSA Journal 2014;12(12):3938 11

dead bacteria have not shown changes in several immunological parameters and liver markers

(Ulsemer et al., 2012b).

Although no safety concerns have been observed, the studies published are insufficient to exclude

safety concerns. The human cohorts used in the pilot studies were small and used killed bacteria on

healthy volunteers. This is a limitation to the use of strains of this species as probiotics, which, by

definition, have to be alive.


Bacteroides xylanisolvens is not recommended for the QPS list, because the body of knowledge is

insufficient and safety concerns cannot be totally excluded.

3.4. Carnobacterium divergens

Identity

The Carnobacterium genus belongs to the family Carnobacteriaceae in the order of Lactobacillales

(Collins et al., 1987). The most important species is Carnobacterium maltaromaticum due to its

common occurrence in foods of animal origin. Carnobacterium divergens (and later also

C. maltaromaticum) has been reclassified and transferred from the genus Lactobacillus to the

described genus nov. Carnobacterium in 1987 (Collins et al., 1987) based on phenotypic

classification. The first description was given by Holzapfel and Gerber (1983). The original strains

were isolated from raw vacuum-packaged, as well as SO2-treated, minced beef, in the course of shelf

life studies on this product (Holzapfel and Gerber, 1983). The complete genome sequence is known

for some strains of Carnobacterium spp., but not for C. divergens.

Body of knowledge

The species C. divergens frequently dominates the microbiota of refrigerated meat and seafood, stored

under vacuum or modified atmosphere (Laursen et al., 2005; Leisner et al., 2007; Rieder et al., 2012).

For its ability to produce bacteriocins, this species has been used in food with the aim to reduce

spoilage and pathogenic bacteria (Richard et al., 2003; Leisner et al., 2007; Rihakova et al., 2009).

C. divergens has been also studied as probiotic for fish, such as Atlantic cod (Gadus morhua L.)

(Lauzon et al., 2010), Atlantic salmon (Salmo salar L.) (Ringø et al., 2007) and rainbow trout

(Oncorhynchus mykiss) (Kim and Austin, 2008), and as probiotic for chicken for fattening (Jozefiak et

al., 2011).

Safety concerns

In a single study two strains of C. divergens, isolated from the blood of a newborn delivered by

caesarean section and from a febrile lymphoma patient, were identified by sequencing the variable

regions of the 16S rRNA gene. The two strains encode a possibly acquired new class A β-lactamase

(Meziane-Cherif et al., 2008). Strains carrying these determinants for resistance can be detected

following the Euzéby and Tindall (online) applying the ampicillin cut off value defined for

“Lactobacillus heterofermentatives”.

However, these infections represent extremely rare individual cases, occurring on highly vulnerable

individuals, so that these microorganisms cannot be considered as pathogenic taking into account the

extent of exposure.


The taxonomic unit is well described and the body of knowledge shows it as a common species in the

food chain, especially in meat. Carnobacterium divergens can be recommended for the QPS list with

the qualification of absence of acquired antibiotic resistance determinants.


EFSA Journal 2014;12(12):3938 12

3.5. Clostridium butyricum

Identity

Clostridium butyricum is a well described species and it is the type species of the genus (Collins et al.,

1994).

Body of knowledge

C. butyricum was assessed as non-suitable for QPS in 2011 because some strains can produce

botulinum toxin E (EFSA Panel on Biological Hazards (BIOHAZ), 2011).

Regarding the history of use, several reports on the use of C. butyricum as probiotic in animals and

humans, were found (Yang et al. (2012); Zhang et al. (2014) on broilers; Uyeno et al. (2013) on

calves; Imase et al. (2008); Sharma et al. (2008); Chen et al. (2010); Sato et al. (2012) on human

subjects). UK the “Advisory Committee on Novel Foods and Processes” issued a draft opinion in 2013

on C. butyricum CBM588 as a novel ingredient to be added to supplements and concluded that “it did

not have any unanswered safety concerns relating to this novel ingredient” (ACNFP, online). These

studies concern a limited number of strains, in particular several used the same strain C. butyricum

CBM588.

Safety concerns

A minority of strains of C. butyricum are able to form botulinum neurotoxin type E, harbouring

BoNT/E gene on a large plasmid (Hauser et al., 1992; Peck, 2009; Ghoddusi and Sherburn, 2010).

Toxigenic strains of this species were responsible for infant botulism (Fenicia et al., 1999; Abe et al.,

2008) and involved in foodborne intoxications. Botulinum neurotoxins are extremely potent toxins.

Methods exists to detect the genes coding for these toxins and to detect the production of the toxins by

the bacteria.

New safety concerns are indicated by one report of bacteremia in a drug addict who very likely

injected himself drug contaminated with C. butyricum (Gardner et al., 2008). C. butyricum was also

suspected to be one of the bacterial species contributing to necrotizing enterocolitis in premature

infants (Waligora-Dupriet et al., 2009; Morowitz et al., 2010). Therefore, C. butyricum has been a rare

cause of human disease in association with very specific risk factors.


The information collected supports the view that the safety of C. butyricum is only known for a few

strains, therefore Clostridium butyricum is not recommended for the QPS list. Thus, no additional

information supports a revision of the previous conclusion attained in 2011.

3.6. Escherichia coli

Escherichia coli was assessed in 2009 as not suitable for the QPS list with the following conclusion:

"although some E. coli (e.g. E.coli Nissle 1917 (EcN)) have a long history of safe use as probiotics,

and in spite of the large body of knowledge acquired for this species, it cannot be recommended for

the QPS list because of the large diversity of human and animal diseases caused by E. coli and the

complexity of the virulence mechanisms (DSMZ, online)".

Identity

E. coli are Gram-negative, facultative anaerobic bacteria, belonging to the family Enterobacteriaceae,

which are taxonomically placed within the gamma subdivision of the Proteobacteria phylum.

E. coli isolates have been divided into subgroups attending to various criteria, either related to

pathogenicity towards the human host, serology (e.g. serotypes O127:H7 or K1) or, mainly for

population genetic purposes, phylogenetic properties of particular housekeeping genes (subdivided in


EFSA Journal 2014;12(12):3938 13

seven major phylogenetic groups A, B1, B2, C, D, E and F) (Jaureguy et al., 2008).The E. coli core

genome corresponds to less than half the pangenome, with most of the E. coli genes in any given

genome being found in some strains, but missing in others (Fukiya et al., 2004; Lukjancenko et al.,

2010).

Body of knowledge

E. coli is a versatile bacterium, both retrieved in the environment or as a commensal of the intestinal

tract of humans and animals. Beside these habitats, certain strains have the potential to cause a wide

spectrum of intestinal and extra-intestinal diseases such as urinary tract infection, septicaemia,

meningitis, and pneumonia in humans and animals.

E. coli, the most extensively studied prokaryote, was brought into laboratories almost a century ago to

become one of the most important model organisms. Some of these laboratory E. coli strains, (e.g.

E. coli K-12) have been used as host organisms, namely for producing aminoacids for use in animal

feed (Bachmann, 1972).

Safety concerns

The ability of an E. coli strain to behave as a commensal or an extra-intestinal pathogen is determined

by a complex balance between many factors, e.g. immune status of the host, production of virulence

factors by the bacterium, portal of entry, inoculum dose, and the genetic background of the bacterium.

Several virulence determinants are recognized, either involved in enteric infection (e.g. enterotoxins

and pili) and/or in extra-intestinal infections (e.g. siderophores, mucinase, cytotoxins,

immunomodulators, lectin-like hemagglutinin and colibactin) (Pacheco and Sperandio, 2012; Ruiz-

Perez and Nataro, 2014). Recently, worrying observations about their potential implication in colon

cancer were described, although apparently associated to a specific phylogenetic group (Nowrouzian

and Oswald, 2012). Moreover, an incomplete understanding of the virulence factors triggering all

clinical disease presentations, including for neonatal meningitis-causing E. coli, still persist

(Wijetunge et al., 2014). These facts prevent the proposal of a set of precise qualifications for QPS

status.


Escherichia coli cannot be proposed for the QPS list as the safety evaluation has to be done on strain

level. No further knowledge supports a revision of the previous conclusion attained in 2009.

3.7. Microbacterium imperiale

Identity

Microbacterium imperiale, previously known as Brevibacterium imperiale, was included in the genus

based on its close relationship to Microbacterium lacticum (Collins et al., 1983). The genus is

phylogenetically coherent as determined by 16S rRNA gene sequencing and chemotaxonomic data

(Takeuchi and Yokota, 1994; Rivas et al., 2004; Park et al., 2006; 2008). The bacteria of the genus

Microbacterium are Gram positive organisms that belong to the Phylum Actinobacteria

(G + C ≈ 66-70 %), strictly aerobic, rod shaped and usually non-motile.

Body of knowledge

Their habitat is the soil where they thrive on plant decaying material thanks to their enzymatic

potential to degrade complex polysaccharides. Xylanolytic, amilolytic and β-glucosidase activities

have been detected in different isolates of the genus (Rivas et al., 2004; Park et al., 2006; 2008; Wu et

al., 2014). Endophytic and gut of caterpillar associated strains have been isolated as well (Zinniel et

al., 2002; Huang et al., 2012; Gan et al., 2014), with no signs of pathology perceived in the colonized

plant or animal tissues.


EFSA Journal 2014;12(12):3938 14

No records of intended use of M. imperiale cells in foods manufacturing exist. However, the enzymes

produced by organisms of the genus are used in food processing. Of special interest to this evaluation

is the use of the 1,4-α-maltotriohydrolase for the production of maltotriose, an oligosaccharide used

for the production of desserts and baked pastries (Anonymous, 2000, 2011; Wu et al., 2014) .

Safety concerns

In literature, no association of M. imperiale to pathology has been reported. In fact, out of the

84 species of the genus Microbacterium only four have been described as involved in human

pathological processes, the cases being extremely rare, occurring in patients with predisposing

conditions and, in some cases, being part of a polymicrobial infection (Alonso-Echanove et al., 2001;

Giammanco et al., 2006; Adames et al., 2010; Enoch et al., 2011; Buss et al., 2014). The frequent need

of a previous life-threatening or immunodeficiency condition for successful Microbacterium spp.

infection may indicate that no significant virulence factors are produced by the species of this genus.

Finally, resistance to chemotherapy appears to be scarce, with an almost universal susceptibility to β-

lactam and glycopeptide antibiotics (Adames et al., 2010; Buss et al., 2014).


No record exists of intended use of any Microbacterium in food processing and/or ingestion of viable

cells. However, there is a history of use in food processing of enzymes produced by Microbacterium

imperiale, therefore it can only be recommended for QPS for enzyme production.

3.8. Paenibacillus lentus

Identity

Paenibacillus lentus was described recently as a new species by Li et al. (2014), as a β-mannanolytic

bacterium isolated from soil.

Body of knowledge

No information was found on P. lentus apart from its description as a new species.

Safety concerns

No experimental information has yet been developed and/or available.


Due to the absence of a body of knowledge apart from the description of the species, Paenibacillus

lentus cannot be proposed for the QPS list.

3.9. Streptomyces albus

Identity

Streptomyces albus is the type species of the genus Streptomyces and appears to be a coherent

taxonomic entity, as judged by 16S rRNA gene sequence and multilocus sequence analysis (Labeda et

al., 2014). The only strain that has been completely sequenced is S. albus J1074 (Olano et al., 2014;

Zaburannyi et al., 2014). This strain does not carry the gene cluster encoding for salinomycin

biosynthesis, thus suggesting a high intraspecies variability.

Body of knowledge

There is a long record of use of salinomycin as an anticoccidial additive, especially with chicken

(Yvoré et al., 1980; Lee et al., 2013). However, cases of accidental salinomycin intoxication to

turkeys, horses, calves and other farm animals that involve internal organ compromise (cardiac and

muscular lesions) and even death have been reported (Potter et al., 1986; Aleman et al., 2007;


EFSA Journal 2014;12(12):3938 15

Holliman et al., 2011). It is not clear in these cases whether salinomycin is being administered as a

pure compound or as a crude extract.

The bacteria of this species are virtually avirulent, although a report exists in which an

actinomycetoma developed in the forearm of a person that had previously been treated with

corticosteroids. The identity of the infection was determined through 16S rRNA gene sequencing

(Martin et al., 2004).

Safety concerns

Apart from the toxicity referred to in the previous paragraph, there are two other reasons for concern:

Salinomycin is demonstrating a potential as an anticancer agent, especially for stem cell and

prostate tumors (Zhou et al., 2013). Its use in feed might promote resistance development as a

consequence of its ingestion with the meat of treated animals.

The sequenced strain S. albus J1074, in spite of not harbouring the cluster for salinomycin

production, has the potential to synthesize 27 secondary metabolites, the majority of which

have antimicrobial properties (Olano et al., 2014; Zaburannyi et al., 2014). The capacity to

produce multiple antimicrobials is general among the streptomycetes that have been

completely sequenced and it can be assumed that this can be the case also for the salinomycin

producer. The potential production of this kind of compounds by S. albus represents a risk of

toxicity and generation of resistance in the intestinal microbiota that might become

subsequently transferred to pathogens.

S. albus appears to be a complex species that includes strains harbouring different sets of gene clusters

that encode a wide variety of metabolites with biological activity. This means that the lack of toxicity

and of antibiotic activity has to be tested on a strain basis.


Streptomyces albus is not recommended for the QPS list, because safety concerns cannot be excluded.

3.10. Streptomyces aureofaciens

Identity

Streptomyces aureofaciens was initially described in 1948 as a narasin producer although, depending

on the strain, it also produces tetracyclines and other biologically active compounds. Its taxonomy was

settled on the basis of extensive phenotypic properties (Groth et al., 2003).

However, no strain belonging to the species has been fully sequenced according to NCBI (Microbial

Genomes, online).

Body of knowledge

There is a long record of using narasin as an anticoccidial additive (Peeters et al., 1981; Jeffers et al.,

1988; Brennan et al., 2001) although the extent of usage is not comparable to that of other polyether

ionophores such as salinomycin and monensin. Accidental narasin intoxication of rabbits and of some

laboratory animal species may involve diarrhea and internal organ compromise, including respiratory

stress, skeletal muscle degeneration and even death (Novilla et al., 1994; Salles et al., 1994; Oehme

and Pickrell, 1999). This toxicity appears to be, however, less pronounced than that of salinomycin

and monensin (Dorne et al., 2013). There are no clinical reports involving S. aureofaciens in human

disease.

Safety concerns



EFSA Journal 2014;12(12):3938 16

Narasin belongs to the same family as that of salinomycin and monensin. These two drugs are

being tested as possible anticancer agents (Zhou et al., 2013; Tumova et al., 2014). The

possibility exists that use of narasin as an additive in feed might promote cross-resistance

development as a consequence of its ingestion with the meat of treated animals.

The biosynthetic capacity of S. aureofaciens cannot be assessed due to lack of information on

its genome. However, the common occurrence of multiple pathways encoding secondary

metabolites among the streptomycetes whose genomes are known, allow hypothesizing that

this might also be the case for this QPS candidate. Many of these secondary metabolites act as

antimicrobials. The potential production of this kind of compounds by S. aureofaciens

represents a risk of toxicity and generation of resistance in the intestinal microbiota that might

become subsequently transferred to pathogens.

Knowledge of the strain and, by extension, of the species it belongs to, is not enough to ensure a safe

application. Especially important is the fact that the ability to produce secondary metabolites appears

to be strain-specific. Finally, narasin seems to have moderate toxicity to man and animals. Under these

circumstances, toxicity and co-production of antibiotics has to be excluded on a strain basis.


Streptomyces aureofaciens is not recommended for the QPS list, because the body of knowledge is

limited and safety concerns cannot be excluded.

3.11. Streptomyces cinnamonensis

Identity

A search in Pub-Med using the key word Streptomyces cinnamonensis, retrieved 69 articles, the vast

majority of which dealt with different aspects of monensin production. No paper on S. cinnamonensis

taxonomic characteristics was found, apart from some that justified classification of S. cinnamonensis

16S rRNA-related strains into new species. Furthermore, no strain belonging to the species has been

fully sequenced according to NCBI (Microbial Genomes, online). All this indicates absence of

coherence of the taxonomic unit.

Body of knowledge

There is a long record of using monensin as an anticoccidial additive (McDougald, 1976; Chapman et

al., 2010; Pirali Kheirabadi et al., 2014). However, cases of accidental monensin intoxication of

chicken, horses and other farm animals that may involve internal organ compromise, including

myocardial and neurological damage and even death have been reported (Matsuoka, 1976; Oehme and

Pickrell, 1999; Zavala et al., 2011). There are no clinical reports involving S. cinnamonensis in human

disease.

Safety concerns


Monensin is being tested as a possible anticancer agent, although the studies are not as

advanced as with salinomycin, another polyether ionophore with a similar mode of

antimicrobial action (Choi et al., 2013; Tumova et al., 2014). Its use in feed might promote

resistance development as a consequence of its ingestion with the meat of treated animals.

The biosynthetic capacity of S. cinnamonensis cannot be assessed due to lack of information

on its genome. However, the common occurrence of multiple pathways encoding secondary

metabolites among the streptomycetes whose genomes are known indicates that this might

also be the case for this QPS candidate. Many of these secondary metabolites act as

antimicrobials. The potential production of this kind of compounds by S. cinnamonensis


EFSA Journal 2014;12(12):3938 17

represents a risk of toxicity and generation of resistance in the intestinal microbiota that might

become subsequently transferred to pathogens.



to be strain-specific. Finally, monensin seems to have moderate toxicity to man and animals. Under

these circumstances, toxicity and co-production of antibiotics has to be excluded on a strain basis.


Streptomyces cinnamonensis is not recommended for the QPS list, because the body of knowledge is

limited and safety concerns cannot be excluded.

3.12. Streptomyces lasaliensis

Identity

The majority of the 13 articles retrieved with the use of the Streptomyces lasaliensis key words were

devoted to the study of the lasalocid genetic cluster and to the production of terpenoids. No paper on

the taxonomy of the species was retrieved. Its identity may be more dependent on production of

lasalocid than on biological characteristics in general. Moreover, no strain belonging to the species has

been fully sequenced according to Microbial Genomes (online).

Body of knowledge

There is a long record of using lasalocid as an anticoccidial additive, with some emphasis on the

treatment of calves (Reid et al., 1975; Stromberg et al., 1982; Fuller et al., 2008) although the extent of

usage is not comparable to that of other polyether ionophores. Intoxication of cattle and horses with

lasalocid may result in myocardial and neurological damage and even death (Galitzer et al., 1986;

Oehme and Pickrell, 1999; Decloedt et al., 2012). This toxicity appears to be, however, less

pronounced than that of salinomycin and monensin (Dorne et al., 2013). There are no clinical reports

involving S. lasaliensis in human disease.

Safety concerns


Lasalocid belongs to the same family of compounds as salinomycin and monensin. These two

drugs are being tested as possible anticancer agents (Zhou et al., 2013; Tumova et al., 2014).

The possibility exists that the use of lasalocid in feed might promote cross-resistance

development as a consequence of its ingestion with the meat of treated animals.

The biosynthetic capacity of S. lasaliensis cannot be assessed due to lack of information on its

genome. However, the common occurrence of multiple pathways encoding secondary

metabolites among the streptomycetes whose genomes are known, allow hypothesizing that

this might also be the case for this QPS candidate. Many of these secondary metabolites act as

antimicrobials. The potential production of this kind of compounds by S. lasaliensis represents

a risk of toxicity and generation of resistance in the intestinal microbiota that might become

subsequently transferred to pathogens.



to be strain-specific. Finally, lasalocid seems to have moderate toxicity to man and animals. Under

these circumstances, toxicity and co-production of antibiotics has to be excluded on a strain basis.


EFSA Journal 2014;12(12):3938 18


Streptomyces lasaliensis is not recommended for the QPS list, because its identity is not well

established, the body of knowledge is limited and safety concerns cannot be excluded.

3.13. General conclusion for the genus Streptomyces on a recommendation for the QPS list

Streptomycetes are essentially non-virulent, with the exception of some plant pathogens such a

S. scabies. However, they produce antibiotics and may thus select for resistant bacteria. Other

secondary metabolites have diverse biological activities that go from depressors of the immune system

to herbicides (Butaye et al., 2003). Genome sequencing has revealed that streptomycetes carry several

gene clusters for the production of secondary metabolites, many of which may be toxic, or select for

antimicrobial resistance. Furthermore, the presence of specific clusters varies on a strain basis. All this

precludes the consideration of any species of the genus as a QPS organism.

4. Yeast

4.1. Candida cylindracea

Identity

C. cylindracea belongs to the Ogataea clade of the Ascomycetous yeasts (Kurtzman et al., 2011;

Daniel et al., 2014). The species was described by Yamada and Machida (1962), and validated by

Meyer and Yarrow (1998). No synonym names have been used. Only the anamorphic form is known

and described. The type strain for C. cylindracea – CBS 6330 – is also marketed under other

designations, e.g. DSMZ 2031 (online) and ATCC 14930 (online). Unfortunately, in the literature on

lipase-producing yeasts, the C. cylindracea type strain has at times been referred to as Candida rugosa

(e.g. Benjamin and Pandey (1998); Takaç et al. (2010)). This has caused some confusion since

C. cylindracea and C. rugosa are two well defined species, not closely related phylogenetically

(Kurtzman et al., 2011). It is also unfortunate since C. rugosa is considered an emerging, opportunistic

yeast (Miceli et al., 2011). However, identification according to molecular methods can easily separate

between the two species. It is therefore recommended that the species identity of lipase-producing

strains of Candida is confirmed by using such methods.

Body of knowledge

C. cylindracea has been used for a long time in industry as a lipase producer (Tomizuka et al., 1966;

Brozzoli et al., 2009). The Ogataea clade to which it belongs does not include the pathogenic yeast

Candida albicans (which belongs to the Lodderomyces-Spathaspora clade) or other Candida species

associated with human infections, like C. tropicalis, C. glabrata, C. parasilopsis or C. rugosa.

Safety concerns

A literature search for “Candida cylindracea” on Thomson Reuters Web of Science (7 July 2014)

gave 797 hits. The vast majority of the retrieved studies treated different aspects of enzyme production

by this species. None of the studies implied a potential safety issue for C. cylindracea. No clinical

reports for C. cylindracea were recovered in the search and the species is not mentioned in reviews on

emerging opportunistic yeasts (e.g. Miceli et al. (2011)). C. cylindracea does not grow at 37 °C

(Kurtzman et al., 2011).


In the Candida cylindracea bibliography, the species was only reported for use as an enzyme producer

and no safety concerns were identified. Therefore it was concluded that it can be recommended for

QPS status. However, since there were no reports on its use in applications involving direct

consumption of Candida cylindracea viable cells by humans or animals, QPS should apply only for

the production of enzymes.


EFSA Journal 2014;12(12):3938 19

CONCLUSIONS AND RECOMMENDATIONS

CONCLUSIONS

ToR 1: Keep updated the list of biological agents being notified, in the context of a technical dossier to

EFSA Units (such as Feed, Food Ingredients and Packaging (FIP), Nutrition and Pesticides), for

intentional use in feed and/or food or as sources of food and feed additives, enzymes and plant

protection products for safety assessment:

Between May 2013 and October 2014, 99 notifications were received from those four Units, of

which 44 from FIP, 47 from Feed, 3 from Nutrition and 5 from Pesticides.

ToR 2: Review taxonomic units previously recommended for the QPS list and their qualifications

(especially the qualification regarding antimicrobial resistance) when new information has become

available:

The work being developed in order to reply to this ToR is not reflected in the current Panel

statement.

This ToR is being dealt with by the QPS working group and the ongoing revision of the overall

assessment of the biological agents included in the 2013 QPS update opinion will be published

through a scientific opinion of the BIOHAZ Panel in December of 2016.

ToR 3: (Re)assess the suitability of taxonomic units notified to EFSA not present in the current QPS

list for their inclusion in that list:

Of those 99 notifications received, 26 biological agents already had a QPS status and were not

further evaluated.

From the remaining 73 (without a QPS status), 54 biological agents were not further assessed as

they are filamentous fungi or enterococci, biological groups which have been excluded from QPS

activities, and 19 were further assessed for the suitability of the respective taxonomic units for

inclusion in the QPS list.

From the assessed taxonomic units, 16 species were notified to the Feed Unit, 2 to the FIP Unit

and one to the Nutrition Unit. The respective taxonomic units (total of 13) were assessed for their

suitability to the QPS list.

Of a total of 12 bacterial taxonomical units evaluated, 10 were notified to the Feed Unit

(Actinomadura roseorufa, Bacillus toyonensis (previously B. cereus var. toyoi), Carnobacterium

divergens, Clostridium butyricum, Escherichia coli, Paenibacillus lentus, Streptomyces albus,

Streptomyces aureofaciens, Streptomyces lasaliensis, Streptomyces cinnamonensis), one to the FIP

Unit (Microbacterium imperiale) and one to the Nutrition Unit (Bacteroides xylanisolvens). The

only yeast taxonomic unit evaluated was notified to the FIP Unit (Candida cylindracea).

For 3 of the 13 taxonomic units assessed, no safety concerns were found than a specific

qualification or an indication for a specific use (food enzyme production), therefore a

recommendation for a QPS status was included and the 2013 updated QPS list.

RECOMMENDATIONS

Three taxonomic units were recommended for the QPS list:

a) Carnobacterium divergens with the qualification of absence of acquired antibiotic resistance

determinants;

b) Microbacterium imperiale only for enzyme production;

c) Candida cylindracea only for enzyme production.


EFSA Journal 2014;12(12):3938 20

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APPENDICES

Appendix A. The 2013 updated list of QPS Status recommended biological agents in support

of EFSA risk assessments – 1st revision (new additions)

The 2013 update list of QPS Status recommended biological agents for safety risk assessments carried

out by EFSA Scientific Panels and Units, as shown in Table 1 below, is undergoing a revision process

in accordance with a self-task mandate of the BIOHAZ Panel. The revisions will be published as an

Appendix to a Statement of the BIOHAZ Panel around every six months, with the first revision in

December 2014 and the last revision as an Appendix to a Scientific Opinion of the BIOHAZ Panel in

December 2016. The most up-to-date QPS list will be published on the web as an Appendix of the

corresponding revision and also as a separate file associated with the respective revision.

Table 1: The 2013 updated list of QPS Status recommended biological agents for safety risk

assessments carried out by EFSA Scientific Panels and Units – 1st revision (new additions)

Gram-Positive Non-Sporulating Bacteria

Species Qualifications *

Bifidobacterium

adolescentis

Bifidobacterium animalis

Bifidobacterium bifidum

Bifidobacterium breve

Bifidobacterium longum

Carnobacterium divergens †††

Corynebacterium

glutamicum**

QPS only applies when

the species is used for

amino acid production

Lactobacillus acidophilus

Lactobacillus amylolyticus

Lactobacillus amylovorus

Lactobacillus alimentarius

Lactobacillus aviaries

Lactobacillus brevis

Lactobacillus buchneri

Lactobacillus casei ***

Lactobacillus cellobiosus

Lactobacillus coryniformis

Lactobacillus crispatus

Lactobacillus curvatus

Lactobacillus delbrueckii

Lactobacillus farciminis

Lactobacillus fermentum

Lactobacillus gallinarum

Lactobacillus gasseri

Lactobacillus helveticus

Lactobacillus hilgardii

Lactobacillus johnsonii

Lactobacillus

kefiranofaciens

Lactobacillus kefiri

Lactobacillus mucosae

Lactobacillus panis

Lactobacillus collinoides

Lactobacillus paracasei

Lactobacillus

paraplantarum

Lactobacillus pentosus

Lactobacillus plantarum

Lactobacillus pontis

Lactobacillus reuteri

Lactobacillus

rhamnosus

Lactobacillus sakei

Lactobacillus salivarius

Lactobacillus

sanfranciscensis

Lactococcus lactis

Leuconostoc citreum

Leuconostoc

pseudomesenteroides

Leuconostoc lactis Leuconostoc

mesenteroides

Microbacterium imperiale †††

QPS only applies when

the species is used for

enzyme production

Oenococcus oeni

Pediococcus acidilactici Pediococcus dextrinicus Pediococcus

pentosaceus

Propionibacterium

freudenreichii

Propionibacterium

acidipropionici

Streptococcus

thermophilus


EFSA Journal 2014;12(12):3938 29

Bacillus

Species Qualifications*

Bacillus

amyloliquefaciens

Bacillus atrophaeus

Bacillus clausii

Bacillus coagulans

Bacillus fusiformis

Bacillus lentus

Bacillus licheniformis

Bacillus megaterium

Bacillus mojavensis

Bacillus pumilus

Bacillus subtilis

Bacillus vallismortis

Absence of toxigenic

activity.

Geobacillus

stearothermophilus

Absence of toxigenic

activity.

Gram-Negative Bacteria

Species Qualifications*

Gluconobacter oxydans

QPS only applies when the

species is used for vitamin

production

Yeasts††

Species Qualifications

Candida cylindracea ††† QPS only applies when the

species is used for enzyme

production

Debaryomyces hansenii

Hanseniaspora uvarum

Kluyveromyces lactis Kluyveromyces marxianus

Komagataella pastoris

Lindnera jadinii

Ogataea angusta



production

Saccharomyces

bayanus****

Saccharomyces

cerevisiae†,****

Saccharomyces

pastorianus****

Schizosaccharomyces

pombe

Wickerhamomyces

anomalus****



production

Xanthophyllomyces

dendrorhous (imperfect

form Phaffia rhodozyma)

Virus

Plant viruses

Family

Alphaflexiviridae Potyviridae

Insect viruses

Family

Baculoviridae * Generic qualification for all QPS bacterial taxonomic units: the strains should not harbour any acquired antimicrobial

resistance genes to clinically relevant antibiotics.

** Brevibacterium lactofermentum is a synonym of Corynebacterium glutamicum *** The previously described species ‘Lactobacillus zeae’ has been included in the species Lactobacillus casei

**** Absence of resistance to antimycotics used for medical treatment of yeast infections in cases where viable cells are

added to the food or feed chain. In the case of Saccharomyces cerevisiae this qualification applies for yeast strains

able to grow above 37 °C.

† Saccharomyces cerevisiae, subtype boulardii is contraindicated for persons with fragile health, as well as for patients

with a central venous catheter in place.

†† Yeast synonyms commonly used in the feed/food industry:

Wickerhamomyces anomalus: synonym Hansenula anomala, Pichia anomola, Saccharomyces anomalus

Lindnera jadinii: synonyms Pichia jadinii, Hansenula jadinii, Torulopsis utilis

Saccharomyces cerevisiae synonym: Saccharomyces boulardii

Saccharomyces pastorianus: synonym Saccharomyces carlsbergensis

Komagataella pastoris: synonym Pichia pastoris

Ogataea angusta: synonym Pichia angusta

Debaromyces hansenii: synonym Candida famata

††† new microorganisms recommended in this Panel Statement published in December 2014


EFSA Journal 2014;12(12):3938 30

Appendix B. Microbial species as notified to EFSA received (May 2013 and October 2014)

EFSA

Unit/Panel

Microorganism

species/strain

Intended use EFSA Register of

Questions and EFSA

Journal

Additional information provided by the

EFSA Scientific Unit

Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Bacteria

Feed/

FEEDAP Actinomadura roseorufa

ATCC 53664

Production of semduramicin

(coccidiostat)

EFSA-Q-2014-00219

FAD-2014-0009

No Yes

Feed/

FEEDAP

Bacillus licheniformis (ATCC

53757)

Zootechnical feed additive EFSA-Q-2013-00630

FAD-2013-0017

Yes No

Feed/

FEEDAP Bacillus toyonensis

(previously B. cereus var.

toyoi)


EFSA Journal

2014;12(7):3766, 17 pp.

http://www.efsa.europa.eu/e

n/efsajournal/pub/3766.htm

Already assessed in several occasions but

now it has been reassigned to this novel

taxonomical unit

No Yes

Feed/

FEEDAP Bifidobacterium animalis ssp.

animalis

DSM 16284


FAD-2014-0011

Already assessed in EFSA-Q-2009-00823 Yes No

Feed/

FEEDAP Carnobacterium divergens

S1


FAD-2013-0048

Very first notification of this species No Yes

Feed/

FEEDAP Clostriduim butyricum CBM

588


EFSA Journal

2014;12(3):3603, 10 pp.



Already assessed in several occasions No Yes

Feed/

FEEDAP

Corynebacterium glutamicum

KCTC 10423BP

Nutritional additives (amino

acid)

EFSA-Q-2014-00296

FAD-2014-0012

Yes No

Feed/

FEEDAP Enterococcus faecium

DSM 21913


FAD-2014-0011

Already assessed in EFSA-Q-2009-00823 No No

Feed/

FEEDAP Escherichia coli/DC231 Nutritional/Production of L-

lysine sulphate

EFSA-Q-2014-00003

FAD-2013-0045

No Yes

Feed/

FEEDAP Escherichia coli FERM BP-

10941

Nutritional/Production of

copper chelate of L-

EFSA-Q-2013-00407

GMM

Production strain of L-Lysine-HCl used in

No Yes

12 Not present in the QPS list as published in the 2013 QPS update scientific opinion (version before the publication of this Panel statement)

http://registerofquestions.efsa.europa.eu/roqFrontend/questionsList.jsf


http://www.efsa.europa.eu/en/publications/efsajournal.htm


http://www.efsa.europa.eu/en/efsajournal/pub/3766.htm





EFSA Journal 2014;12(12):3938 31

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Lysinate-HCl EFSA Journal

2014;12(7):3796, 20 pp.



EFSA-Q-2014-00496

FAD-2014-0021

the manufacturing of the additive

Feed/

FEEDAP Escherichia coli K-12/

AG7056X


threonine

EFSA-Q-2013-00676

EFSA Journal

2014;12(10):3825, 14 pp.



No Yes

Feed/


AG8012X


tryptophan

EFSA-Q-2013-00677

EFSA Journal

2014;12(10):3826, 13 pp.



No Yes

Feed/


INTK-01X


lysine

EFSA-Q-2013-00823

EFSA Journal

2014;12(11):3895, 20 pp.



No Yes

Feed/

FEEDAP Escherichia coli VA-05 Nutritional additives (amino

acid)

EFSA-Q-2014-00299

FAD-2014-0015

GMM No Yes

Feed/

FEEDAP Lactobacillus casei

LOCK 0915


FAD-2013-0048

Yes No

Feed/

FEEDAP Lactobacillus lactis IBB500



FAD-2013-0048

WG Comment: should be moved to QPS


Yes No

Feed/

FEEDAP Lactobacillus plantarum

LOCK 0862


FAD-2013-0048

Yes No














EFSA Journal 2014;12(12):3938 32

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Feed/

FEEDAP Lactobacillus salivarius ssp.

salivarius

DSM 16351


FAD-2014-0011

Already assessed in EFSA-Q-2009-00823 Yes No

Feed/

FEEDAP Paenibacillus lentus

DSM 28088

Zootechnical feed additive

Production of enzyme

EFSA-Q-2014-00115

FAD-2014-0001

No Yes

Feed/

FEEDAP Pediococcus acidilactici

(CNCM) MA 18/5M


FAD-2010-0122

Already assessed in several occasions Yes No

Feed/

FEEDAP Pediococcus acidilactici

(CNCM) MA 18/5M


FAD-2013-0031


Feed/

FEEDAP Streptomyces albus

ATCC 21838

Production of salinomycin

sodium (coccidiostat)

EFSA-Q-2013-00706

FAD-2013-0029

EFSA-Q-2013-00998

FAD-2013-0053

EFSA-Q-2014-00350

FAD-2014-0016

It will be validated end of 2014. The full

registration number is ATCC21838/US

9401-06

No Yes

Feed/

FEEDAP Streptomyces albus

NCIMB 30321

Production of salinomycin


EFSA-Q-2014-00350

FAD-2014-0016

It will be validated end of 2014.

The applicant is presenting two production

strains in the same application.

Accordingly, one mandate has been sent

by the EC.

No Yes

Feed/

FEEDAP

Streptomyces aureofaciens

NRRL 8092

Production of narasin

(coccidiostat)

EFSA-Q-2013-00767

FAD-2013-0041

No Yes

Feed/

FEEDAP Streptomyces cinnamonensis

ATCC 15413

Production of monensin


EFSA-Q-2013-00752

FAD-2013-0037

No Yes

Feed/

FEEDAP Streptomyces lasaliensis

ATCC 31180

Production of lasalocid A


EFSA-Q-2013-00813

FAD-2013-0040

No Yes

FIP/CEF Bacillus subtilis MAM Production of Food Enzyme EFSA-Q-2013-00790

FIP-2013-0071

The food enzyme is a glucans 1,4-alpha

glucosidase and produced by a GMM

strain

Yes

No

FIP/CEF Bacillus subtilis XAS Production of Food Enzyme EFSA-Q-2014-00293

FIP-2014-0029

The food enzyme is a endo 1,4-beta

xylanase and produced by a GMM strain

Yes No






EFSA Journal 2014;12(12):3938 33

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

FIP/CEF Bacillus licheniformis NZYM-

AC

Production of Food Enzyme EFSA-Q-2013-00586

FIP-2013-0043

The food enzyme is an alpha-amylase

produced by a GMM strain

Yes

No


BC


FIP-2013-0066



Yes

No


KE


FIP-2012-0051



Yes No


RH


FIP-2014-0028

The food enzyme is a Serine protease


Yes

No

FIP/CEF Microbacterium imperiale

AE-AMT


FIP-2014-0063

The food enzyme is an alpha-amylase No Yes

Nutrition/

NDA

Pasteurised milk products

fermented with Bacteroides

xylanisolvens

As a Novel Food ingredient EFSA-Q-2014-00301

Under validation

A safety assessment under the framework

of Novel Foods

No Yes

Nutrition/

NDA

A combination of four

bacterial strains:

Bifidobacterium longum LA

101, Lactobacillus helveticus

LA 102, Lactococcus lactis

LA 103 and Streptococcus

thermophilus LA 104

Food targeted for health

claims: “improvement of

bowel function by increasing

stool frequency”

EFSA-Q-2013-00893

EFSA Journal

2014;12(5):3659, 10 pp.



An intake of one sachet (2.5 g) per day for

28 days. The concentration of the bacterial

strains in colony forming units (CFU) is of

1010

CFU/per sachet (2.9×109 CFU B.

longum LA 101; 2.9×109 CFU L.

helveticus LA 102; 2.9×109 CFU L. lactis

LA 103; 1.3×109 CFU S. thermophilus LA

104)

In the framework of the EU Regulation

1924/2006 on health claims made on

foods, EFSA is only requested to perform

efficacy assessment (i.e. relationship

between the food consumption and the

claimed beneficial effect). Safety

assessment is not foreseen.

NA No








EFSA Journal 2014;12(12):3938 34

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Nutrition/

NDA

Combination of four bacterial

strains: Bifidobacterium

longum LA 101, Lactobacillus

helveticus LA 102,

Lactococcus lactis LA 103

and Streptococcus

thermophilus LA 104

Food targeted for health

claims: “reducing intestinal

discomfort”

EFSA-Q-2013-00892

EFSA Journal

2014;12(5):3658, 10 pp.



The concentration of the bacterial strains

in colony forming units (CFU) is of 1010

CFU/per sachet (2.9×109 CFU B. longum

LA 101; 2.9×109 CFU L. helveticus LA

102; 2.9×109 CFU L. lactis LA 103;

1.3×109 CFU S. thermophilus LA 104)

Safety assessment is not foreseen.

NA No

Nutrition/

NDA

Synbio, a combination of

Lactobacillus rhamnosus IMC

501® and Lactobacillus

paracasei IMC 502®

EFSA-Q-2014-00567

0425_IT

Notes: In the framework of the EU

Regulation 1924/2006 on health claims

made on foods, EFSA is only requested to

perform efficacy assessment (i.e.

relationship between the food consumption

and the claimed beneficial effect). Safety

assessment is not foreseen.

Yes No

Filamentous fungi

Feed/

FEEDAP

Aspergillus niger

(CBS 18404)


(production of enzyme)

EFSA-Q-2013-00886

EFSA Journal

2014;12(6):3723, 9 pp.



EFSA-Q-2014-00291

FAD-2014-0007

Already assessed in EFSA-Q-2008-013a No No

Feed/

FEEDAP Aspergillus niger

(CBS 109.713)



EFSA-Q-2013-00886

EFSA Journal

2014;12(6):3723, 9 pp.



EFSA-Q-2014-00291

FAD-2014-0007

Already assessed in EFSA-Q-2008-013a No No












EFSA Journal 2014;12(12):3938 35

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Feed/


MUCL 39199


(product of enzyme)

EFSA-Q-2014-00229

FAD-2010-0227

No No

Feed/


NRRL 25541


(product of enzyme)

EFSA-Q-2014-00503

FAD-2014-0019

EFSA-Q-2014-00504

FAD-2014-0018

Already assessed in EFSA-Q2010-01519

and EFSA-Q-2010-00585

No No

Feed/


Strains: ZLCA0323

Van Tieghem ZS9

TN-A09

Production of Citric Acid EFSA-Q-2013-00612

FAD-2012-0048

No No

Feed/

FEEDAP Aspergillus oryzae

DSM 17594


(product of enzyme)

EFSA-Q-2014-00450

FAD-2014-0017

GMM already assessed in EFSA-Q-2007-

133

No No

Feed/

FEEDAP

Aspergillus oryzae

DSM 22594



EFSA-Q-2014-00289

FAD-2014-0008


Feed/


DSM 26372


(product of enzyme)

EFSA-Q-2014-00447

FAD-2013-0047

GMM already assessed in EFSA-Q-2008-

419

No No

Feed/


NRRL 66222


(product of enzyme)

EFSA-Q-2014-00503

FAD-2014-0019

Already assessed in EFSA-Q2010-01519 No No

Feed/

FEEDAP Penicillium funiculosum

(Talaromyces versatilis

sp.nov. DSM 26702)


EFSA Journal

2014;12(7):3793, 20 pp.



EFSA-Q-2014-00463

FAD-2014-0020

GMM

No No








EFSA Journal 2014;12(12):3938 36

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

Feed/

FEEDAP Penicillium funiculosum

(Talaromyces versatilis IMI

378536)



EFSA-Q-2013-00750

EFSA Journal

2014;12(7):3793, 20 pp.



EFSA-Q-2014-00463

FAD-2014-0020


Feed/

FEEDAP Trichoderma citroviridae

(IMI SD 135)



EFSA-Q-2013-00809

FAD-2013-0046


Feed/

FEEDAP Trichoderma citroviridae

(IMI SD 142)



EFSA-Q-2014-00297

FAD-2014-0013


Feed/

FEEDAP Trichoderma longibrachiatum

MUCL 39203


(product of enzyme)

EFSA-Q-2014-00228

FAD-2010-0213


Feed/

FEEDAP Trichoderma reesei

(ATCC SD-6528)



EFSA-Q-2013-00997

FAD-2013-0049

GMM strain No No

FIP/CEF Aspergillus acidus/ RF7398 Production of Food Enzyme EFSA-Q-2014-00163

FIP-2014-0020

The food enzyme is a endo 1,4-

betaxylanase produced by a GMM strain

No No

FIP/CEF Aspergillus aculeatus/

NZYM-RE

CBS 589.94


FIP-2014-0024

EFSA-Q-2014-00201

FIP-2014-0025

The food enzyme is a polygalacturonase

The food enzyme is a betaglucanase

No No

FIP/CEF Aspergillus melleus/AE-DN Production of Food Enzyme EFSA-Q-2014-00326

FIP-2014-0037

The food enzyme is an AMP deaminase No No

FIP/CEF Aspergillus niger Production of Food Enzyme EFSA-Q-2013-01018

FIP-2013-0082

The food enzyme is a glucose oxidase and

catalase

No No

FIP/CEF Aspergillus niger/AGN Production of Food Enzyme EFSA-Q-2014-00401

FIP-2014-0059

The food enzyme is an asparaginase


No No

FIP/CEF Aspergillus niger/DS 53180 Production of Food Enzyme EFSA-Q-2013-00895

FIP-2013-0077



No No

FIP/CEF Aspergillus niger/EPG Production of Food Enzyme EFSA-Q-2014-00402

FIP-2014-0060

The food enzyme is a polygalacturonase


No No








EFSA Journal 2014;12(12):3938 37

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

FIP/CEF Aspergillus niger/NZYM-BE Production of Food Enzyme EFSA-Q-2013-00896

FIP-2013-0078

The food enzyme is a glucoamylase


No No

FIP/CEF Aspergillus niger/NZYM-BF Production of Food Enzyme EFSA-Q-2014-00307

FIP-2014-0032

The food enzyme is a glucoamylase


No No

FIP/CEF Aspergillus niger/NZYM-BR Production of Food Enzyme EFSA-Q-2013-00686

FIP-2013-0067

The food enzyme is an amyloglucosidase


No No

FIP/CEF Aspergillus niger/NZYM-BX Production of Food Enzyme EFSA-Q-2013-00877

FIP-2013-0073

The food enzyme is a glucan 1,4-alpha-

glucosidase with activity also of an alpha

amylase produced by a GMM strain

No No

FIP/CEF Aspergillus niger/NZYM-MC Production of Food Enzyme EFSA-Q-2014-00306

FIP-2014-0031

The food enzyme is an alpha amylase


No No

FIP/CEF Aspergillus niger/NZYM-SB Production of Food Enzyme EFSA-Q-2014-00413

FIP-2014-0053



No No

FIP/CEF Aspergillus niger/LFS Production of Food Enzyme EFSA-Q-2014-00325

FIP-2014-0036

The food enzyme is a tryacylglycerol

lipase produced by a GMM strain

No No

FIP/CEF Aspergillus niger/XYL Production of Food Enzyme EFSA-Q-2014-00305

FIP-2014-0030

The food enzyme is a Endo-1,4-beta-

xylanase produced by a GMM strain

No No

FIP/CEF Aspergillus niger/ZGL Production of Food Enzyme EFSA-Q-2013-01005

FIP-2013-0080

The food enzyme is a glucose oxidase


No No

FIP/CEF Aspergillus oryzae/AE-TL Production of Food Enzyme EFSA-Q-2014-00112

FIP-2014-0014

The food enzymes are triacylglycerol

lipase and transesterase

No No

FIP/CEF Aspergillus oryzae/NZYM-AL Production of Food Enzyme EFSA-Q-2013-00198

EFSA Journal

2014;12(7):3778, 2 pp.



The food enzyme is a lipase produced by a

GMM strain

No No

FIP/CEF Aspergillus oryzae/NZYM-FA Production of Food Enzyme EFSA-Q-2013-00789

FIP-2013-0070

The food enzyme is a xylanase produced

by a GMM strain

No No








EFSA Journal 2014;12(12):3938 38

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

FIP/CEF Aspergillus oryzae/NZYM-FL Production of Food Enzyme EFSA-Q-2013-00197

EFSA Journal

2014;12(7):3762, 15 pp.




GMM strain

No No

FIP/CEF Aspergillus oryzae/NZYM-KE Production of Food Enzyme EFSA-Q-2012-00897

EFSA Journal

2014;12(5):3645, 17 pp.



The food enzyme is a xylanase produced

by a GMM strain

No No

FIP/CEF Aspergillus oryzae/NZYM-KP Production of Food Enzyme EFSA-Q-2013-00687

FIP-2013-0065

The food enzyme is a glucose oxidase


No No

FIP/CEF Aspergillus oryzae/

NZYM-LH


EFSA Journal

2014;12(7):3763, 15 pp.




GMM strain

No No


NZYM-NA


FIP-2013-0007

The food enzyme is an alpha-amylase No No


NZYM-SP


FIP-2013-0044



No No

FIP/CEF Disporotrichum

dimorphosporum/DXL


FIP-2014-0040

EFSA-Q-2014-00356

FIP-2014-0041

The food enzymes is a Endo-1,4-beta-

xylanase & beta-glucanase

No No

FIP/CEF Fusarium venenatum Production of Food Enzyme EFSA-Q-2014-00412

FIP-2014-0052

The food enzyme is a trypsin produced by

a GMM strain

No No

FIP/CEF Leptographium procerum Production of Food Enzyme EFSA-Q-2013-01006

FIP-2013-0081

The food enzyme is a phosphodiesterase

produced

No No

FIP/CEF Penicillium roqueforti AE- Production of Food Enzyme EFSA-Q-2014-00545 The food enzymes is a triacylglycerol No No












EFSA Journal 2014;12(12):3938 39

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated

LRF FIP-2014-0064 lipase

FIP/CEF Rhyzopus oryzae/AE-MB Production of Food Enzyme EFSA-Q-2014-00114

FIP-2014-0016

The food enzymes are leucyl

aminopeptidase, protease and amylase

No No

FIP/CEF Rhyzopus oryzae/AE-PER Production of Food Enzyme EFSA-Q-2014-00354

FIP-2014-0038

The food enzymes is a leucyl

aminopeptidase

No No

FIP/CEF Trichoderma citrinoviride/

TCLSC


FIP-2014-0062

The food enzyme is an endo-1,4-β-

xylanase

No No

FIP/CEF Trichoderma reesei/RF5703 Production of Food Enzyme EFSA-Q-2014-00410

FIP-2014-0050

The food enzyme is a endo 1,4-

betaxylanase produced by a GMM strain

No No


FIP-2014-0021

The food enzyme is a pectine lyase No No


FIP-2014-0051

The food enzyme is a phospholipase A2


No No

Pesticides/

PPR

Beauveria bassiana

strain NPP111B005

Plant protection product EFSA-Q-2014-00327 No No

Pesticides/

PPR

Beauveria bassiana

strain 147

Plant protection product EFSA-Q-2014-00324 No No

Pesticides/

PPR

Isaria fumosorosea

strain Apopka 97

Plant protection product EFSA-Q-2013-00833

EFSA Journal

2014;12(5):3679, 23 pp.



It has been formerly evaluated as

Paecilomyces fumosoroseus (DG SANCO,

4203/VI/98-final) and approved in 2001,

now resubmitted for renewal of the

approval.

No No

Pesticides/

PPR

Trichoderma atroviride SC1 Plant protection product EFSA-Q-2014-00334 No No

Yeasts

Feed/

FEEDAP Komagataella pastoris

(DSMZ 25376)



EFSA-Q-2013-00528

FAD-2013-0013

GMM

Yes No

Feed/


(DSMZ 26469)



EFSA-Q-2013-00528

FAD-2013-0013

GMM Yes No

Feed/


(DSM 26643)

Technological/ Production

of fumonisine esterase

EFSA-Q-2013-00090

EFSA Journal

2014;12(5):3667, 19 pp.

GMM

Synonym used: Pichia pastoris

Yes No








EFSA Journal 2014;12(12):3938 40

EFSA

Unit/Panel

Microorganism

species/strain


Questions and EFSA

Journal



Previous

QPS

status? 12

To be

evaluated/

not

evaluated



Feed/

FEEDAP Saccharomyces cerevisiae

LOCK 0141


FAD-2013-0048

Not validated yet Yes No

Feed/


CNCM I-1077


FAD-2013-0054


Feed/


CNCM I-1077


FAD-2010-0120

Not validated yet

Already assessed in several cases

Yes No

FIP/CEF Candida cylindracea

AE-LAYH


FIP-2014-0015

The food enzyme is a tryacilglycerol lipase

by a GMM strain

Enzymes for this microorganisms has been

used in bakery products

No Yes

FIP/CEF Saccharomyces cerevisiae

CBS615-94


EFSA Journal

2013;11(7):3304, 28 pp.



The food enzyme is an alpha-galactosidase


Yes No

Nutrition/

NDA

Saccharomyces cerevisiae

(vitamin D-enriched UV-

treated)

Scientific Opinion on the

safety of vitamin D-enriched

UV-treated baker’s yeast

The source for the

production of the novel food

ingredient is Saccharomyces

cerevisiae

EFSA-Q-2013-00335

EFSA Journal

2014;12(1):3520, 19 pp.



Safety assessment

As a novel food ingredient in the context

of Regulation (EC) No 258/97

Yes

No

Virus

Pesticides/

PPR

Pepino mosaic virus, strain

CH2, isolate 1906

Plant protection product EFSA-Q-2014-00054 Yes No












EFSA Journal 2014;12(12):3938 41

ABBREVIATIONS

CEF EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids

FEED EFSA Feed Unit

FEEDAP EFSA Panel on Additives and Products or Substances used in Animal Feed

FIP EFSA Food ingredients and packaging Unit

IJSEM International Journal of Systematic and Evolutionary Microbiology

LPSN List of prokariotic names with standing in nomenclature

NDA EFSA Panel on Dietetic Products, Nutrition and Allergies

NUTRI EFSA Nutrition Unit

PPR Panel on Plant Protection Products and their Residues

PRAS EFSA Pesticides Unit

QPS Qualified Presumption of Safety

ToR Term of Reference

statement on the update of the list of qps-recommended ... · b. cereus var. toyoi), carnobacterium...

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